Early detection and prevention of symptomatic post-surgical hypoparathyroidism after thyroid surgery
Official title: PRESS -PAR: Early Detection and PREvention of Symptomatic postSurgical hypoPARathyroidism After Thyroid Surgery"
Run by University of Wuerzburg · NCT07491601 · Data updated 2026-11-12
This project tests whether measuring parathyroid hormone earlier after thyroid surgery and starting calcium plus active vitamin D when needed can reduce how many patients develop symptoms from low parathyroid function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 336 (estimated) |
| Sponsor | University of Wuerzburg Academic / other |
| Locations | 1 site (Würzburg, Bavaria) |
| Status | Recruiting |
| Started | January 8, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07491601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older undergoing total or bilateral thyroidectomy who can give informed consent and do not have preexisting parathyroid disease or prior neck surgery are ideal candidates.
✕Probably not a fit
Patients with existing parathyroid disorders, prior neck surgery, pregnant or breastfeeding individuals, or those unable to attend required perioperative visits are unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls adults undergoing total or bilateral thyroidectomy and performs early perioperative measurements of parathyroid hormone, calcium, and vitamin D, using an algorithm to guide prompt calcium and active vitamin D supplementation when indicated. Baseline data and patient-reported outcomes (SF-36, STAI-G, HPQ28, and a modified HPES symptom scale) are collected, with postoperative clinical visits on days 0, 1, and 2 and a planned six-month follow-up. Recruitment is planned over three years at the University Hospital Wuerzburg and excludes patients with preexisting parathyroid disease, prior neck surgery, pregnancy or breastfeeding, or inability to attend visits. The goal is to create a clear perioperative management algorithm to reduce symptomatic hypoparathyroidism, improve quality of life, and potentially shorten hospital stays.
Why it matters
Potential benefit: If successful, this approach could reduce symptomatic hypoparathyroidism after thyroidectomy, improve patients' quality of life, and shorten hospital stays.
How similar studies have gone: Previous PTH-guided supplementation protocols have shown reductions in symptomatic hypocalcemia in several studies, though methods and patient selection have varied and large confirmatory trials are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Thyroidectomy or bilateral thyroid resection of any indication * Written informed consent obtained after detailed patient information and provision of an information sheet Exclusion Criteria: * Age ≤ 18 years * Concomitant parathyroid disease (primary or secondary hyperparathyroidism, pre-existing hypoparathyroidism of any cause) * Previous surgery in the neck region * Pregnancy or breastfeeding * Inability to attend study visits * Participation in another study that interferes with the endpoints * Missing or inadequate patient information
Where it's running
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Dept. Surgery I; University Hospital Wuerzburg
Würzburg, Bavaria, Germany Recruiting
Study contacts
- Principal investigator: Nicolas Schlegel, Prof. Dr. (MD) — Wuerzburg University Hospital
- Study coordinator: Nicolas Schlegel, Prof. Dr. (MD)
- Email: SCHLEGEL_N@ukw.de
- Phone: +49 931 201 38217
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using PTeye to help protect parathyroid glands during total thyroidectomy
This trial will test whether using the handheld PTeye device during total thyroidectomy in adults reduces the chance of low blood calcium after surgery.
-
Indapamide to reduce urinary calcium in post-surgical hypoparathyroidism
This trial will test whether taking indapamide once daily for 14 days lowers urinary calcium in adults with chronic post-surgical hypoparathyroidism.
-
Parathyroid tissue transplant into the forearm for chronic hypoparathyroidism
This project will try transplanting donated parathyroid tissue into the forearm of adults with chronic hypoparathyroidism to raise PTH and help normalize their calcium and phosphorus levels.
-
PTeye versus surgeon’s eye for finding and protecting parathyroid glands during total thyroid removal
This trial will test whether using the PTeye near-infrared probe during first-time total thyroidectomy in adults helps surgeons find and preserve parathyroid glands better than using the surgeon’s naked eye.
-
Factors linked to low parathyroid function after thyroid removal
We will see if magnesium levels and other patient or surgical factors are linked to developing low parathyroid function after removal of both thyroid lobes in adults.
-
Lower- versus higher-dose calcium replacement after thyroid removal
This will test whether a lower-dose calcium plan works as well as a higher-dose plan to prevent symptoms of low parathyroid function in adults after thyroid removal.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.